MK0653C in High Cardiovascular Risk Patients With High Cholesterol (Switch Study)(MK-0653C-162)

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Atorvastatin; Atorvastatin Calcium; Ezetimibe; Rosuvastatin Calcium

Criteria

Inclusion Criteria:

• Patient is at high cardiovascular risk and meets one of the following conditions: has never taken lipid-lowering therapy or has been off such therapy for at least 6 weeks; or, is currently taking a stable dose of certain lipid-lowering agents

• Patient is willing to maintain a cholesterol lowering diet during the study

• Female patients receiving non-cyclical hormone therapy have maintained a stable dose and regimen for at least 8 weeks and are willing to continue the same regimen during the study

Exclusion Criteria:

• Patient is Asian

• Patient routinely has more than 2 alcoholic drinks per day

• Female patient is pregnant or breastfeeding

• Patient has congestive heart failure

• Patient has had a myocardial infarction, coronary bypass surgery, angioplasty, or acute coronary syndrome within 3 months of screening

• Patient has uncontrolled cardiac arrhythmias

• Patient has had a partial ileal or gastric bypass or other significant intestinal malabsorption

• Patient has uncontrolled high blood pressure

• Patient has kidney disease

• Patient has any disease known to influence blood lipid levels

• Patient has any disorders of the blood, digestive system, or nervous system including stroke and degenerative disease that would limit study participation

• Patient has poorly controlled or newly diagnosed diabetes

• Patient is known to be HIV positive

• Patient has a history of cancer in the last 5 years, except certain skin and cervical cancers